Restless Legs SyndromePhase 3NCT00314860
RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole
A Phase 3 study testing ropinirole Extended Release (XR) in people with Restless Legs Syndrome and Restless Legs Syndrome (RLS), run by GlaxoSmithKline at 91 sites in 13 countries.
Trial summary
Restless Legs Syndrome (RLS) study in adults comparing immediate release ropinirole with extended release ropinirole over 12 weeks Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Restless Legs Syndrome, Restless Legs Syndrome (RLS)
- What is being tested?
- ropinirole Extended Release (XR)
- How many people
- 568 participants
- Where
- 91 sitesin 13 countries
- Study dates
- Feb 2006to Dec 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of primary RLS according to RLS Diagnostic Clinical Interview and International Restless Legs Syndrome Study Group Diagnostic Criteria.
- Disturbed sleep, with both evening (between 5:00 pm and 8:00 pm) and night time (between 8:00 pm and 8:00 am) symptoms requiring treatment.
Who cannot join
- Signs of secondary RLS.
- Primary sleep disorder or movement disorder other than RLS.
- Unstable medical conditions.
- Inability to tolerate dopamine agonists or dopamine antagonists.
- Unwilling to discontinue any medications currently being taken to treat RLS symptoms.
Trial locations and contacts
91 sites in 13 countries.
91 sites in 13 countries
United States28 sites
GSK Investigational Site
Albany, New York, 12205
GSK Investigational Site
Anaheim, California, 92801
GSK Investigational Site
Birmingham, Alabama, 35209
GSK Investigational Site
Boca Raton, Florida, 33486
GSK Investigational Site
Burlingame, California, 94010
GSK Investigational Site
Burlington, Vermont, 05401
GSK Investigational Site
Coeur d'Alene, Idaho, 83814
GSK Investigational Site
Fargo, North Dakota, 58104
GSK Investigational Site
Kalamazoo, Michigan, 49048
GSK Investigational Site
Las Vegas, Nevada, 89119
GSK Investigational Site
Long Beach, California, 90806
GSK Investigational Site
Mesa, Arizona, 85210
GSK Investigational Site
Newport Beach, California, 92660
GSK Investigational Site
Oklahoma City, Oklahoma, 73104
GSK Investigational Site
Pasadena, California, 91106
GSK Investigational Site
Phoenix, Arizona, 85050
GSK Investigational Site
Redondo Beach, California, 90277
GSK Investigational Site
Saint Paul, Minnesota, 55101
GSK Investigational Site
Santa Monica, California, 90404
GSK Investigational Site
Springfield, Massachusetts, 01104
GSK Investigational Site
St Louis, Missouri, 63128
GSK Investigational Site
Stanford, California, 94305-5548
GSK Investigational Site
Sun City, Arizona, 85351
GSK Investigational Site
Tabor City, North Carolina, 28463
GSK Investigational Site
Warwick, Rhode Island, 02886
GSK Investigational Site
West Yarmouth, Massachusetts, 02673
GSK Investigational Site
Winnetka, California, 91306
GSK Investigational Site
Worcester, Massachusetts, 01655
France9 sites
GSK Investigational Site
Anzin, 59410
GSK Investigational Site
Bordeaux, 33000
GSK Investigational Site
Bron, 69677
GSK Investigational Site
Créteil, 94010
GSK Investigational Site
Grenoble, 38043
GSK Investigational Site
Lille, 59037
GSK Investigational Site
Montbrison, 42600
GSK Investigational Site
Nancy, 54035
GSK Investigational Site
Pessac, 33604
Spain8 sites
GSK Investigational Site
Barcelona, 08017
GSK Investigational Site
Barcelona, 08025
GSK Investigational Site
Barcelona, 08035
GSK Investigational Site
Granada, 18013
GSK Investigational Site
Madrid, 28036
GSK Investigational Site
Palma de Mallorca, 07014
GSK Investigational Site
San Sebastián, 20014
GSK Investigational Site
Zaragoza, 50009
United Kingdom8 sites
GSK Investigational Site
Blackpool, Lancashire, FY4 3AD
GSK Investigational Site
Chesterfield, Derbyshire, S40 4TF
GSK Investigational Site
Corsham, SN13 8NA
GSK Investigational Site
Coventry, Warwickshire, CV6 4DD
GSK Investigational Site
Doncaster, DN1 2EG
GSK Investigational Site
Frome, Somerset, BA11 1EZ
GSK Investigational Site
Ledbury, HR8 2DX
GSK Investigational Site
Trowbridge, Wiltshire, BA14 9AR
Netherlands7 sites
GSK Investigational Site
Amsterdam, 1066 EC
GSK Investigational Site
Geldermalsen, 4191 AH
GSK Investigational Site
Grubbenvorst, 5971 BB
GSK Investigational Site
Hoogwoud, 1718 BG
GSK Investigational Site
Nieuwegein, 3435 CM
GSK Investigational Site
Roelofarendsveen, 2371 RB
GSK Investigational Site
Zwolle, 8025 BV
Germany6 sites
GSK Investigational Site
Berlin, State of Berlin, 12163
GSK Investigational Site
Chemnitz, Saxony, 09111
GSK Investigational Site
Gera, Thuringia, 07551
GSK Investigational Site
Köthen, Saxony-Anhalt, 06366
GSK Investigational Site
Munich, Bavaria, 80331
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, 19053
Italy5 sites
GSK Investigational Site
Bologna, Emilia-Romagna, 40123
GSK Investigational Site
Milan, Lombardy, 20127
GSK Investigational Site
Pavia, Lombardy, 27100
GSK Investigational Site
Pisa, Tuscany, 56126
GSK Investigational Site
Rome, Lazio, 00168
Belgium4 sites
GSK Investigational Site
Brussels, 1190
GSK Investigational Site
Charleroi, 6000
GSK Investigational Site
Edegem, 2650
GSK Investigational Site
Liège, 4000
Denmark4 sites
GSK Investigational Site
Glostrup Municipality, 2600
GSK Investigational Site
Hvidovre, 2650
GSK Investigational Site
Koebenhavn NV, 2300
GSK Investigational Site
Odense C, DK-5000
Sweden4 sites
GSK Investigational Site
Gothenburg, SE-412 55
GSK Investigational Site
Gothenburg, SE-413 45
GSK Investigational Site
Helsingborg, SE-252 21
GSK Investigational Site
Örebro, 701 85
Australia3 sites
GSK Investigational Site
Auchenflower, Queensland, 4066
GSK Investigational Site
Camperdown, New South Wales, 2050
GSK Investigational Site
Kippa-Ring, Queensland, 4021
Norway3 sites
GSK Investigational Site
Bergen, 5094
GSK Investigational Site
Oslo, 0277
GSK Investigational Site
Sandvika, N-1338
Austria2 sites
GSK Investigational Site
Innsbruck, A-6020
GSK Investigational Site
Vienna, A-1090
About this study
Official title: A 12-Week, Randomized, Double-Blind, Parallel Group, Multicentre Study to Assess the Tolerability and Clinical Benefits of Ropinirole Extended Release (XR) Tablets Compared With Ropinirole Immediate Release (IR) Tablets in Subjects With Restless Legs Syndrome (RLS)
Restless Legs Syndrome (RLS) study in adults comparing immediate release ropinirole with extended release ropinirole over 12 weeks
- Being tested
- ropinirole Extended Release (XR)
- Keywords
- Restless Legs Syndrome
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropinirole Extended Release (XR)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the superior tolerability of ropinirole extended release compared to ropinirole immediate release in adult subjects with RLS requiring evening and night-time coverage of RLS symptoms
Measured: 12 Weeks
Secondary outcomes (1)
To compare the safety profile and to evaluate the clinical benefits (as assessed by efficacy endpoints and patient-reported outcomes) of ropinirole extended release compared to ropinirole immediate release in subjects with RLS.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2006 (estimated)
- Study startFeb 2006
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 568 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314860
- Sponsor's protocol ID
- 101468/204
- Status last verified
- Oct 2016
- First submitted
- 13 Apr 2006
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Randomized, Double-Blind, Parallel Group, Multicentre Study to Assess the Tolerability and Clinical Benefits of Ropinirole Extended Release (XR) Tablets Compared With Ropinirole Immediate Release (IR) Tablets in Subjects With Restless Legs Syndrome (RLS)
- ClinicalTrials.gov ID
- NCT00314860
- Acronym / sponsor ID
- 101468/204
- Keywords
- Restless Legs Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 568 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 17 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Restless Legs Syndrome (RLS) study in adults comparing immediate release ropinirole with extended release ropinirole over 12 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of primary RLS according to RLS Diagnostic Clinical Interview and International Restless Legs Syndrome Study Group Diagnostic Criteria.
- Disturbed sleep, with both evening (between 5:00 pm and 8:00 pm) and night time (between 8:00 pm and 8:00 am) symptoms requiring treatment.
Key exclusion criteria (5 listed)
- Signs of secondary RLS.
- Primary sleep disorder or movement disorder other than RLS.
- Unstable medical conditions.
- Inability to tolerate dopamine agonists or dopamine antagonists.
- Unwilling to discontinue any medications currently being taken to treat RLS symptoms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ropinirole Extended Release (XR) | Drug | – |
Primary outcome
To demonstrate the superior tolerability of ropinirole extended release compared to ropinirole immediate release in adult subjects with RLS requiring evening and night-time coverage of RLS symptoms
Time frame: 12 Weeks
1 secondary outcome
To compare the safety profile and to evaluate the clinical benefits (as assessed by efficacy endpoints and patient-reported outcomes) of ropinirole extended release compared to ropinirole immediate release in subjects with RLS.
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
91 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ropinirole Extended Release (XR) in people with Restless Legs Syndrome and Restless Legs Syndrome (RLS), run by GlaxoSmithKline at 91 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 91 sites in United States, France, Spain, United Kingdom, Netherlands and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate the superior tolerability of ropinirole extended release compared to ropinirole immediate release in adult subjects with RLS requiring evening and night-time coverage of RLS symptoms (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.